Clinical Trials

TxBDC has published seven clinical trials since our founding in 2012.

Spinal Cord Injury

On February 20, 2020 we received FDA approval for the first in human study using the ReStore Vagus Nerve Stimulator to enhance recovery following a spinal cord injury. TxBDC is currently in the planning stage of a clinical trial using VNS therapy for upper limb rehabilitation in patients with Spinal Cord Injury. Recruitment for this trial is anticipated to begin in the fall of 2020. If you would like to be notified when recruiting begins please send an email to [email protected].

Stroke

On June 3, 2020 we received FDA approval for the first in human study using the ReStore Vagus Nerve Stimulator to enhance recovery after stroke. TxBDC is currently in the planning stage of this clinical trial. Recruitment for this trial is anticipated to begin in the fall of 2020. If you would like to be notified when recruiting begins please send an email to [email protected].

Follow this link for information about our three published clinical trials in stroke.

Targeted Plasticity Therapy

Mark, a 34-year-old army veteran, was one of 60 people who participated in the TPT clinical safety trial for Tinnitus. He suffers from a constant, high-pitched ringing that he describes as a teapot shrieking in his head, as a result of an explosion in battle.

PTSD

On April 15, 2020 the Texas Biomedical Device Center (TxBDC) at The University of Texas at Dallas received FDA approval to proceed with an early feasibility study using the ReStore Vagus Nerve Stimulator to enhance prolonged exposure therapy for treating Post Traumatic Stress Disorder (PTSD). TxBDC is currently in the planning stage of this clinical trial. Recruitment for this trial is anticipated to begin in the fall of 2020. If you would like to be notified when recruiting begins please send an email to [email protected].

Tinnitus

We are not currently running any clinical trials for tinnitus. TxBDC conducted initial research and development into the VNS therapy for Tinnitus; after which one of our partner companies, MicroTransponder, further developed the technology and brought the treatment to clinical trials.

Further information regarding Tinnitus and VNS therapy can be found on MicroTransponder’s website.

VIDEO: Mark's Story
VIDEO: Robert's Story
VIDEO: Serenity System for Tinnitus

Follow this link for information about our four published clinical trials in tinnitus.

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